Artoss Foot and Ankle Surgery Registry

Completed

• Conditions: Deformity; Bone; Trauma Injury; Arthritis Foot
• Interventions: Other: NanoBone Bone Graft Substitute

• Registration Number: NCT04503759
• Lead Sponsor: Artoss Inc.

Brief Summary

This prospective registry was designed as an observational study to ascertain how commercially available NanoBone products are being used by surgeons performing foot and ankle surgery which involves bone grafting, as well as determining relevant patient outcomes.

Detailed Description

This multicenter prospective patient registry was developed with the aim of documenting how surgeons are utilizing NanoBone products in foot and ankle surgery along with relevant patient outcomes. These outcomes include radiographic measures such as fusion or graft consolidation success, instrumentation integrity, and clinical outcomes (symptom and function improvement) based on investigator and patient-based outcome assessments.

The primary objective of this study is to document and analyze the use of NanoBone products in foot and ankle surgery (as a stand-alone bone graft, no other local bone, autograft, bone graft substitute, or biologic product used) and determine both radiographic success and clinical outcomes. All product related adverse events will be documented, tabulated, and summarized.

Study Timeline

• Study First Submitted: 2020-07-30
• Study Start: 2020-08-01
• Study First Submitted QC: 2020-08-05
• Study First Posted: 2020-08-07
• Status Verified: 2024-05
• Primary Completion: 2024-05-10
• Study Completion: 2024-05-10
• Last Update Submitted: 2024-05-10
• Last Update Posted: 2024-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patient aged 18 years or older.
• Patient is or was diagnosed with a pathology of the foot or ankle, having failed conservative treatment, and surgeon has determined that surgery with bone graft is medically necessary.
• The surgeon has determined that NanoBone is or was clinically indicated.
• NanoBone will be or was used as a stand-alone bone graft (no autograft, other bone graft substitute, or biologic planned or used).
• Patient capable of understanding the content of the Informed Consent Form
• Patient willing and able to participate in the registry protocol including the surgeon's standard follow-up visits and clinical evaluations.
• Patient who has agreed to participate in the registry by providing consent according to the applicable local law and the declaration of Helsinki.

Exclusion Criteria

• Severe vascular or neurological disease
• Uncontrolled diabetes
• Severe degenerative disease (other than degenerative disc disease)
• Severely impaired renal function
• Hypercalcemia, abnormal calcium metabolism
• Existing acute or chronic infections, especially at the site of the operation
• Inflammatory bone disease such as osteomyelitis
• Malignant tumors
• Patients who are or plan to become pregnant.
• Uncooperative patients who cannot or will not follow post-operative instruction, including individuals who abuse drugs and/or alcohol.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Foot and Ankle Surgery using NanoBone	NanoBone Bone Graft Substitute	All patients in the study will be drawn from the individual surgeons' practice. Patients will be among those already scheduled for foot and ankle surgery after having failed conservative treatment, or will have had foot and ankle surgery using NanoBone products but have not completed their standard of care follow-up as determined by the surgeon's practice. In addition, the surgeon has determined that the use of a NanoBone product is or was clinically necessary for the patient. The choice of a NanoBone product, as well as the surgery, is or was independent of this research project. Only patients who have had NanoBone implanted and consent to participate and meet the inclusion-exclusion criteria will be included in the registry.

Primary Outcome Measures

Name	Time	Method
Radiographic Success	6-months	Fusion/Graft Consolidation: Evidence of bony (osseous) bridging between the graft material and the patient's bone in the segment requiring fusion or reconstruction.

Secondary Outcome Measures

Name	Time	Method
Safety Evaluation	6-months	Occurrence of Complications or Adverse Events

Trial Locations

Locations (8)

Florida Orthopedic Foot & Ankle Center; 🇺🇸 Sarasota, Florida, United States

Orthopedic Associates of Duluth; 🇺🇸 Duluth, Minnesota, United States

Podiatry Associates of Indiana; 🇺🇸 Indianapolis, Indiana, United States

Phoenix Foot and Ankle Institute; 🇺🇸 Scottsdale, Arizona, United States

Hoosier Foot and Ankle; 🇺🇸 Kokomo, Indiana, United States

Illinois Orthopedic Institute; 🇺🇸 Joliet, Illinois, United States

Morrison Hospital; 🇺🇸 Morrison, Illinois, United States

The Iowa Clinic; 🇺🇸 West Des Moines, Iowa, United States